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NCT Number: NCT07220759

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires Mácula, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Female or male (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.(a*)
  • Body mass index (BMI) >= 27.0 kilogram per square meter (kg/m^2).(a*)
  • Diagnosed with type 2 diabetes >= 180 days before screening.
  • Treatment with either lifestyle intervention(a*), or:
  • Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a*)
  • For up to 30% of participants the following concomitant medication is allowed:
  • Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a*) and/or
  • Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day [U/day]) stable for at least 90 days before screening.(a*)

Key Exclusion Criteria:

  • Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a*)
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(a*)
  • Previous dosing of marketed or non-marketed amylin-based compounds.(a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo (matched to Cagrilintide)

Drug

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Primary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as percentage (%) of body weight.

  2. Number of participants with achievement of greater than or equals (>=) 5% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

Secondary outcomes

  1. Number of participants with achievement of >= 10% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

  2. Number of participants with achievement of >= 15% body weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants.

  3. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as centimeter (cm).

  4. Ratio to baseline in lipids: triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  5. Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  6. Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

  7. Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as kilogram (kg).

  8. Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.

  9. Change in SF-36v2® mental component summary score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.

  10. Change in IWQOL-Lite-CT total score

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.

  11. Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT physical function score (yes/no)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.

  12. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as millimeter of mercury (mmHg).

  13. Change in diastolic blood pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmHg.

  14. Ratio to baseline in lipids: total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  15. Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  16. Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  17. Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  18. Ratio to baseline in lipids: non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  19. Ratio to baseline in lipids: free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  20. Change in glycated haemoglobin (HbA1c) in percentage-points (%-points)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as %-points.

  21. Change in HbA1c in millimole per mole (mmol/mol)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmol/mol.

  22. Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mmol/L.

  23. Change in FPG in milligram per deciliter (mg/dL)

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as mg/dL.

  24. Ratio to baseline in fasting serum insulin

    Time frame: From baseline (week 0) to end of treatment (week 64)

    Measured as ratio.

  25. Number of treatment emergent adverse events

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

  26. Number of treatment emergent serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

  27. Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

  28. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (week 0) to end of study (week 71)

    Measured as count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

Acronym: RENEW 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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